Keratoconus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Confirmed diagnosis of keratoconus by a clinician. 2.Aged 18–65 years, capable of understanding and cooperating with all study examinations, voluntarily participating and signing the informed consent form. 3.The severity staging of keratoconus will be determined by an experienced corneal specialist, based on the Chinese Expert Consensus on the Diagnosis and Treatment of Keratoconus published in 2019 by the Corneal Disease Group of the Ophthalmology Branch of the Chinese Medical Association.
Exclusion criteria
Exclusion criteria: 1.Concomitant other ocular diseases (e.g., moderate to severe dry eye disease, active ocular inflammation, etc.); 2.History of ocular surgery (excluding corneal cross-linking), ocular trauma, or corneal transplantation. 3.Systemic diseases affecting corneal nerves or corneal sensitivity (e.g., diabetes mellitus, rheumatoid arthritis, vitamin A/B12 deficiency, etc.); 4.Use of medications affecting corneal nerves within the past 1 month (e.g., topical corticosteroids, antihistamines, etc.); 5.Severe hepatic or renal insufficiency (especially CCR <0.8 mL/min/kg); or patients with electrolyte disorders; 6.Pregnant or breastfeeding patients, or subjects of childbearing potential (male and female) who plan to become pregnant during the study or are unwilling to use contraception; 7.Subjects with psychiatric or psychological disorders; 8.Systemic diseases deemed by the investigator to make the subject unsuitable for participation in this study; 9.Subjects unable to complete all study examinations as required;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subbasal corneal nerve parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Corneal sensitivity (NCCA);Corneal biomechanical parameters;Baseline demographic and clinical data;Corneal tomographic parameters;Ocular Surface Disease Index (OSDI);Corneal sensitivity(CBA);Tear film break-up time and corneal epithelial integrity; | — |
Countries
China
Contacts
Eye Hospital, Wenzhou Medical University